510(k) Report

Devices descending from K113201

15 later devices reach Narval CC through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153291Sicat OptisleepSicat GmbH & Co. KG20163—
+1K143244The Panthera Anti-Snoring DevicePanthera Dental, Inc.20149—
+1K140435Medley GoldAmerican Dental Sleep Medicine, Ip, LLC20140—
+2K232025Hushd Pro AveraGood Sleep CO Pte, Ltd.20241—
+2K203596Panthera Occlusal AppliancePanthera Dental, Inc.20212—
+2K202651NOA Sleep Apnea and Snoring DeviceOrthoapnea S.L.20210—
+2K202499Diamond Digital Sleep Orthotic (DDSO)Diamond Orthotic Laboratory20200—
+2K182661Kava and Kava with HerbstSketchpad Innovations, LLC20191—
+2K171576The Panthera Anti-Snoring X3 DevicePanthera Dental, Inc.20181—
+2K170053Meridian PMThe Center For Craniofacial & Dental Sleep Medicine20170—
+3K252976Park Dental Nylon MADPark Dental Research Corp.20250—
+3K251784Hushd Pro Z-LinkGood Sleep CO Pte, Ltd.20250—
+3K230495Serena Sleep Night GuardMeris Investment Group20231—
+3K221889ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device…Prosomnus Sleep Technologies20220—
+4K230548Myoaligner ApplianceMyohealth Technologies, LLC20240—